Responsible for direct oversight of the Automation Systems and coordination and management of the Process Automation efforts for the campus. Implement existing instrumentation and control systems strategies, further guide instrumentation and automation systems and project software execution. Plan, develop and oversee budgets and strategic staffing plans. Provides engineering discipline leadership and management to the Automation Engineering Group and will provide operational Automation engineering support for existing manufacturing operations with respect to instrumentation and controls of the process equipment, clean and plant utility systems.
Develop, implement and oversee all activities for the Automation department, ensuring strategies and objectives align with overall corporate objectives.
Provide leadership and guidance to subordinate staff including performance management and career development.
Develop strategic relationships with key automation service partner companies like Emerson, Allen Bradley, OSI Pi, etc.
Oversee automation systems staff to ensure that the system infrastructure operate per GMP standards to meet site Make-Assess-Release needs.
Plan, direct and oversee the interface between Automation Engineering, Process Engineering, Manufacturing, MSAT, Maintenance, Electrical, Mechanical, IT, QA and QC as required to support project goals, objectives and responsibilities.
Ensure timely completion of project Automation Engineering related activities by ensuring resource identification and availability, and by ensuring priorities are identified and communicated in support of established timelines and schedules.
Provide oversight of project auxiliary systems activities and scopes of work from various internal Groups and external consultants and/or contractors.
Ensure accuracy and tracking of Automation Engineering documentation on the project by monitoring and/or performing audits.
Develop, implement and oversee the Automation Engineering budget.
Plan, implement and oversee multi-phase projects in support of corporate objectives. This will include selection of external resources, contract negotiations and on-site supervision of contracted staff.
Prepare regular reports regarding engineering activities, schedule, resource needs, and budgetary updates and communicate pertinent information to senior management. Recommend actions to address adverse findings and/or identify cost effective modifications to current processes as applicable.
Produce and review design drawings, including P&IDs, which contain all line sizing, and Automation philosophies. Supervise external consulting engineers; provide control systems overview and review drawings and documents produced by these groups.
Provide direction to sub-contracting groups in the design and installation of Automation systems relating to process, utilities and building systems. Overview design specification testing and perform field inspection services.
Interact with vendors, and select vendors based on the most appropriate combination of price, technical suitability, quality and delivery. Review and approve vendor information packages, including drawings and specifications. Perform factory inspections of vendor-supplied equipment, to ensure that construction and performance meets specifications.
Play a key leadership role in the start-up and troubleshooting of process equipment and critical process utility systems by providing technical engineering expertise to management and staff.
Supervise the generation and provide Automation Engineering review and approval of controlled documents to support the start-up, operation, validation and maintenance of equipment and systems located in the facility.
Provide key input, review and approval into the validation of Automation of process equipment and associated utilities. Assist manufacturing and operations staff in the execution of validation protocols.
Collaborate with other Automation Engineering Groups in order to develop “best practice” engineering solutions company-wide.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Engages in proactive measures to promote a positive safety culture to ensure the protection of people, property, and the environment through group communications about EHS aspects at the company, review of EHS performance metrics and incident reports. Participates in incident investigations and CAPAs, conducts monthly work area tours to assess EHS aspects in the work area and orally communicates one on one with employees in their work area to gauge employee issues and concerns. Fosters a positive safety culture in which no one gets hurt.
Education and Experience
Bachelor’s degree in Electrical, Industrial Automation or Chemical Engineering.
12 years experience in Automation Engineering including 7 years in a supervisory role in the Biological/Pharmaceutical Industry.
Experience with Successful startup and maintenance of Automation Systems Infrastructure, MES, PCS, and PLC systems
Experience with engineering, design, and implementation of complex PLC and/or DSC systems in the Process Industry.
Knowledge, Skills and Abilities
Current knowledge of GAMP for PCS, MES, and PLC systems as applied to Biopharmaceutical production.
Current knowledge of FDA validation requirements in equipment, Instrumentation and computer systems.
Comprehensive experience with translating complex P&IDs into Process Descriptions and subsequent design documents (Functional Requirement Specifications, Detailed Design Specifications).
Working knowledge of ISA S88 batch standards as applied to pharmaceutical or biotech large-scale projects.
Thorough knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sanitary and sterile operations.
Thorough knowledge of biopharmaceutical process operation and process control.
Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation.
Ability to generate engineering drawings and specifications.
Experience in engineering principles applied to safety in design and operation of equipment.
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.